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BurstDR Spinal Cord Stimulation Versus Sham in Established Responders

Not yet recruitingNot applicableNCT07779733
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This study aims to determine whether ongoing BurstDR spinal cord stimulation (SCS) provides pain relief beyond sham stimulation in patients with chronic pain who are established responders to BurstDR therapy. Participants already implanted with an SCS system and experiencing stable clinical benefit from BurstDR will undergo both active stimulation and sham stimulation in a randomized, double-blind crossover design. Each participant will therefore serve as their own control. The primary question is whether pain intensity is lower during active BurstDR stimulation compared with sham stimulation. The study will also evaluate treatment satisfaction, patient-reported changes in sleep, mood, daily activity and social activity, the effectiveness of blinding, and short-term safety and tolerability.

Study details

Official title
Passive Recharge Burst Spinal Cord Stimulation vs Sham Stimulation in Established Responders: A Randomized, Double-Blind Crossover Clinical Trial
Conditions
Interventions
  • Device: BurstDR Spinal Cord Stimulation
  • Device: Sham Spinal Cord Stimulation
Sponsor
Umeå University
Start date
2026-09-30
Primary completion
2026-12-31
Sex
All
Results posted
No results posted in this snapshot
Countries
Sweden
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria Participants must meet all of the following: 1. Be 18 years of age or older. 2. Have an implanted spinal cord stimulation system that can deliver BurstDR stimulation. 3. Have had a good and stable response to BurstDR therapy, defined as at least a 50% reduction in pain compared with pain before implantation or before starting BurstDR therapy, maintained for at least 3 months on stable stimulation settings. 4. Have had no major change in pain medication for at least 4 weeks before entering the study. 5. Be able to understand the study information and provide written informed consent. 6. Be willing and able to complete the study's electronic diaries and follow the study procedures. Exclusion Criteria Participants cannot take part if any of the following apply: 1. An active infection, wound problem, or other significant problem at the site of the implanted spinal cord stimulation system. 2. A known or suspected problem with the implanted stimulation system that could affect treatment delivery or safety. 3. A serious uncontrolled mental health condition, significant problems with memory or thinking, or another condition that could make it difficult to understand the study, provide informed consent, follow the study procedures, or provide reliable study information. 4. Planned surgery, planned changes to spinal cord stimulation programming outside the study, or an expected change in pain medication during the study period. 5. Pregnancy or breastfeeding. 6. Inability to use the electronic diary system when no practical alternative or assistance can be provided. 7. Any other medical or personal condition that, in the investigator's judgment, would make participation unsafe or inappropriate.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07779733